Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries

Phase 4

Withdrawn

• Conditions: Chronic Shoulder Pain
• Interventions: Drug: Lidocaine 1% Injectable Solution; Drug: Triamcinolone Injection; Procedure: Suprascapular Nerve Block

• Registration Number: NCT05364099
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of using suprascapular nerve block for individuals with chronic spinal cord injury who have chronic shoulder pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Status Verified: 2023-11
• Study Start: 2023-11-27
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female, 18-70 years of age, inclusive. 2 Neurological impairment secondary to SCI that occurred at least twelve (12) months prior to the Screening Visit; neurological level of injury between C6 and L5, inclusive.

2. Non-ambulatory, except for exercise or therapy purposes. 4. Uses a manual wheelchair. 5 History of chronic shoulder pain for ≥6 months that has been unresponsive to conservative treatment (e.g. physical therapy, pharmacological agents), and is rated as ≥4 out of 10 on an 11-point Numeric Rating Scale (NRS) (0 = "no pain"; 10 = "most intense pain imaginable") for average shoulder pain intensity during the week leading up to the Screening Visit.

3. Able and willing to comply with the protocol. 7. Able to give voluntary informed consent prior to the performance of any study-specific procedures.

Exclusion Criteria

1. Contra-indications to the procedure (e.g. infection, coagulopathy)
2. History of active cancer within 5 years
3. Adhesive capsulitis
4. Prior history of regenerative medicine intervention
5. Glucocorticoid injection within the past four weeks
6. Any medical condition, including psychiatric illness, which would interfere with the interpretation of the study results or the conduct of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group	Lidocaine 1% Injectable Solution	Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group	Triamcinolone Injection	Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group	Suprascapular Nerve Block	Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.

Primary Outcome Measures

Name	Time	Method
Number of participants at each Global Satisfaction Rating (GSR)	1 month post procedure	Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Number of participants reporting treatment related adverse events	Up to 12 months	As per treating physician evaluation of participant adverse events related to the intervention

Secondary Outcome Measures

Name	Time	Method
Number of participants at each Global Satisfaction Rating	Up to 12 months post procedure	Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Change in NRS scores	Baseline, 12 months	Numerical rating scores (NRS) ranges from 0 to 10 with highest score indicating the maximum pain and the lowest score indicating the lowest amount of pain.
Change in DASH Questionnaire scores	Baseline, 12 months	Disability of the Arm, Shoulder, and Hand (DASH) questionnaire is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point Likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Change in BPI-I scores	Baseline, 12 months	Brief Pain Inventory pain Interference items (BPI-I) scores ranges from 0-10 with the higher scores indicating greater pain.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States